The letter cites concerns that the implementation process for the new market-based payment methodology for the Clinical Lab Fee Schedule (CLFS) will be improperly rushed since CMS has yet to issue a final rule.

The letter states:

“Updating the CLFS is a highly complex task with significant implications for all stakeholders, with a reach far beyond the Medicare program. We believe the critical alterations to the CLFS must be accomplished in a deliberate and measured manner, so that laboratories have sufficient time, once the final rule and subregulatory guidance are issued, to comply. Given the delays in the rulemaking process, the January 1, 2017 effective date for the new CLFS payment methodology is not feasible and should be delayed.”

The letter also points out that while Section 216 of PAMA called for a January 1, 2017 implementation date for the new payment system, the legislation also included two other deadlines of significance that have not yet been met by CMS, including publication of a final rule by June 30, 2015, and reporting of prices beginning on January 1, 2016.

Expressing concern that these deadlines have not been met by CMS, the letter states:

“Congress set up this specific set of milestones to ensure that laboratories and CMS would have sufficient time to collect, report, submit and analyze private payor data, and establish new reimbursement rates. We strongly believe this timeframe is necessary to successfully implement market-based reform.”

“The clinical laboratory community greatly appreciates the leadership of Representatives Tiberi, Pascrell and Meehan in calling for fairness and reason as we undertake this transition to a market-based payment system,” said Alan Mertz, President of the ACLA. “A successful transition – marked by reasonable and achievable milestones for clinical laboratories – is in the best interest of patients, clinical laboratories, and the Medicare program as whole.”

The ACLA is a not-for-profit association representing the nation’s leading national, regional and esoteric clinical laboratories on key issues of common concern, including federal and state government reimbursement and regulatory policies.